U.S. patent application number 12/447617 was filed with the patent office on 2010-03-04 for devices and methods for the treatment of heart failure.
Invention is credited to David Stephen Celermajer.
Application Number | 20100057192 12/447617 |
Document ID | / |
Family ID | 39364100 |
Filed Date | 2010-03-04 |
United States Patent
Application |
20100057192 |
Kind Code |
A1 |
Celermajer; David Stephen |
March 4, 2010 |
DEVICES AND METHODS FOR THE TREATMENT OF HEART FAILURE
Abstract
A device (10) for treating heart failure in a patient. The
device (10) comprising a body (12), at least one passage (18)
through the body (12), at least one one way valve (20) in the
passage (18) and a mounting means (14) adapted for mounting the
body (12) in an opening provided in the patient's atrial septum. In
use, the device (10) is oriented such that, when the patient's left
atrial pressure exceeds the patient's right atrial pressure by a
predetermined amount, the one way valve(s) (20) opens to allow
blood flow through the passage(s) from the left atrium to the right
atrium to thereby reduce the left atrial pressure.
Inventors: |
Celermajer; David Stephen;
(Vaucluse, AU) |
Correspondence
Address: |
WILMERHALE/DC
1875 PENNSYLVANIA AVE., NW
WASHINGTON
DC
20006
US
|
Family ID: |
39364100 |
Appl. No.: |
12/447617 |
Filed: |
November 7, 2007 |
PCT Filed: |
November 7, 2007 |
PCT NO: |
PCT/AU2007/001704 |
371 Date: |
April 28, 2009 |
Current U.S.
Class: |
623/1.26 |
Current CPC
Class: |
A61F 2/2412 20130101;
A61F 2/2475 20130101; A61B 2017/00592 20130101; A61B 2017/00867
20130101; A61F 2/24 20130101; A61B 17/02 20130101; A61B 2017/00575
20130101; A61F 2/2442 20130101; A61B 2017/00606 20130101; A61B
17/0057 20130101; A61M 27/002 20130101; A61B 2017/00252 20130101;
A61B 2017/0237 20130101; A61F 2/06 20130101 |
Class at
Publication: |
623/1.26 |
International
Class: |
A61F 2/24 20060101
A61F002/24; A61F 2/82 20060101 A61F002/82 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 7, 2006 |
AU |
2006906202 |
Claims
1-60. (canceled)
61. A device for treating a heart condition in a patient, the
device comprising: a body defining at least one passageway; at
least one valve disposed the passage and the body including a
mounting surface adapted for mounting the body in an opening in the
patient's atrial septum, wherein the at least one valve is adapted
to open and allow blood flow through the passage from the left
atrium to the right atrium to thereby reduce the left atrial
pressure when the patient's left atrial pressure exceeds the
patient's right atrial pressure by a predetermined amount and
prevent flow from the right atrium to the left atrium when the
right atrial pressure exceeds the left atrial pressure.
62. A device for treating pulmonary venous hypertension in a
patient, the device comprising: a body defining at least one
passageway; at least one valve disposed the passage and the body
including a mounting surface adapted for mounting the body in an
opening in the patient's venous system, the venous system having a
natural flow direction, wherein the at least one valve is adapted
to open and allow blood flow through the passage in the device to
thereby allow flow through the passage when the pressure exceeds
the a predetermined amount and prevent flow in a direction opposite
the natural flow direction.
63. The device as recited in 62, wherein the device is adapted to
be fitted into one of the inferior vena cava, superior vena cava,
the hepatic vein, an iliac vein, and pulmonary veins.
64. A device for treating lower limb venous hypertension in a
patient, the device comprising: a body defining at least one
passageway; at least one valve disposed the passage and the body
including a mounting surface adapted for mounting the body in an
opening in the patient's venous system, the venous system having a
natural flow direction, wherein the at least one valve is adapted
to open and allow blood flow through the passage in the device to
thereby allow flow through the passage when the pressure exceeds
the a predetermined amount and prevent flow in a direction opposite
the natural flow direction.
65. The device as recited in claim 64, wherein the body is in the
form of a stent.
66. The device as recited in claim 65, wherein the body is in the
form of an expandable stent.
67. The device recited in claim 61, wherein the valve is one of a
duckbill valve, a leaflet valve, a flap valve, a disc in cage type
valve and a ball in cage type valve.
68. The device recited in claim 67, wherein the valve is biased in
a closed position.
69. The device as recited in claim 67, wherein the valve is
constructed of a resilient material and is biased to the closed
position by the force applied by the resilient material.
70. The device as recited in claim 61, wherein the valve opens when
the predetermined amount of pressure differential is approximately
2 mm Hg.
71. The device is claimed in claim 61, wherein the valve opens when
the predetermined amount of pressure differential is approximately
5 to 25 mm Hg.
72. The device as recited in claim 61, wherein the valve opens when
the predetermined amount of pressure differential is approximately
5 to 15 mm Hg.
73. The device as recited in claim 61 wherein body defines a single
passageway into which a valve is disposed.
74. The device as recited in claim 73, wherein the body includes a
central axis and the single passage is located along the central
axis of the body.
75. The device is claimed in claim 73, wherein the body includes a
central axis and the single passage is located off the central axis
of the body.
76. The device as recited in claim 61, wherein the body defines a
plurality of passageways through the body and further comprising a
one way valve in each passageway.
77. The device is claimed in claim 76, wherein the device includes
a central axis and the plurality of passageways are located off the
central axis of the body.
78. A device for treating heart failure in a patient, the device
comprising: a body defining at least one passageway; a mesh
disposed the passage and the body including a mounting surface
adapted for mounting the body in an opening in the patient's atrial
septum, the mesh forming apertures sized to allow blood to pass
through the mesh and inhibit the flow of thrombus through the mesh,
wherein the mesh is adapted to allow blood flow through the passage
from the left atrium to the right atrium to thereby reduce the left
atrial pressure when the patient's left atrial pressure exceeds the
patient's right atrial pressure by a predetermined amount.
79. The device as recited in claim 78, wherein passageway defined
by the device includes a first end and the mesh is disposed on the
device at the first end of the passageway.
80. The device as recited in claim 78, wherein passageway defined
by the device includes a first end and a second end and the mesh is
disposed on the device at the first end of the passageway and a
second mesh is disposed on the second end of the passageway.
81. The device as recited in claim 78, wherein the apertures have a
maximum dimension of less than 4 mm
82. The device as recited in claim 81, wherein the apertures have a
maximum dimension of less than 2 mm.
83. The device as recited in claim 78 wherein the mesh is adapted
for preventing thrombosis or endothelialisation of the opening in
the patient's atrial septum by one or more drugs associated with
the mesh.
84. The device as recited in claim 83, wherein the one or more
drugs are selected from a group of heparin, sirolimus and
paclitaxel.
85. The device as recited in claim 78, wherein the body defines a
single passage through the body.
86. The device as recited in claim 85, wherein device includes a
central axis and the single passage is located along the central
axis.
87. The device as recited in claim 85, wherein device includes a
central axis and the single passage is located off the central
axis.
88. The device as recited in claim 85, wherein the body defines a
plurality of passageways through the body and a mesh is disposed in
each passageway.
89. The device as recited in claim 88, wherein the device includes
a central axis and the plurality of passages are each located off
the axis.
90. The device as recited in claim 61, wherein the device is
flexible and is deliverable to a implant site via a catheter.
91. The device as recited in claim 90, wherein the device is formed
from a material which can be deformed but later return to its
original shape.
92. The device as recited in claim 91, wherein the device is formed
at least in part from Nitinol.
93. The device as recited in claim 61, wherein the device includes
a first configuration that has a reduced cross sectional profile
and a second configuration that is adapted for implantation in the
body, the first configuration being adapted to deliver the device
via a catheter.
94. The device as recited in claim 61, wherein the device is
collapsible to a size able to pass through an opening made in the
patient's atrial septum and adapted to return to a shape where at
least some of the device would be unable to pass through the
opening in the patient's atrial septum.
95. The device as recited in claim 94, wherein the device is formed
at least in part by a Nitinol mesh.
96. The device as recited in any one of the claims 61, wherein
mounting surface includes at least one flange having a radial
dimension larger than the opening in the patient's septum.
97. The device as recited in claim 96, wherein the mounting surface
includes a pair of spaced apart flanges having a dimension larger
than the opening in the patient's septum.
98. The device as recited in claim 96, wherein the external
dimensions of the body, remote the flange(s), are substantially
equal to the internal dimensions of the opening in the patient's
atrial septum.
99. The device as recited in claim 96, wherein the at least one
flange is adapted for attaching to the patient's septum by one of
gluing, suturing, stapling and pinning.
100. The device as recited in claim 97, wherein the flanges are
spaced apart by about the thickness of the patient's atrial septum
and are adapted to locate the patient's atrial septum between the
flanges.
101. The device as recited in claim 97, wherein the flanges are
spaced apart by about the thickness of the patient's atrial septum
and are adapted to grip the patient's atrial septum between the
flanges.
102. A method for treating a heart condition in a patient, the
method comprising the steps of: forming an opening in the patient's
atrial septum; inserting at least one valve in the opening such
that the at least one valve allows blood flow through the passage
from the left atrium to the right atrium when the patient's left
atrial pressure exceeds the patient's right atrial pressure; and
securing the at least one valve relative to the patient's atrial
septum, whereby, when the patient's left atrial pressure exceeds
the patient's right atrial pressure, by a predetermined amount, the
at least one valve opens to allow blood flow through the passage
from the left atrium to the right atrium to thereby reduce the
patient's left atrial pressure and the valve prevents and the valve
prevents flow when the right atrial pressure exceeds the left
atrial pressure.
103. The method recited in claim 102 wherein step of securing the
valve to operate at a predetermined pressure is at an amount of
pressure differential of approximately 2 mm Hg.
104. The method recited in claim 103 wherein step of securing the
valve to operate at a predetermined pressure is at an amount of
pressure differential between approximately 5 and 25 mmHg.
105. The method as recited in claim 103 wherein step of securing
the valve to operate at a predetermined pressure is at an amount of
pressure differential between approximately 5 to 15 mm Hg.
106. A method for treating heart failure in a patient, the method
comprising the steps of: forming an opening in the patient's atrial
septum; inserting a mesh within the opening having apertures
therein of a size permitting passage of blood, inhibiting the
passage of thrombi; and, securing the mesh or grill arrangement
relative to the patient's atrial septum.
107. The method as claimed in claim 106, wherein the mesh or grill
arrangement is provided within a passage in a body, and the method
includes the step of securing the body relative to the patient's
atrial septum.
108. A method for treating heart failure in a patient, the method
comprising the steps of: inserting at least one valve in the
patient's venous system, orienting the at least one valve in the
venous system such that the at least one valve allows blood flow
through the venous system in the natural flow direction and
prevents blood flow through the said venous system in a direction
opposite to that of the natural flow direction; and securing the at
least one valve relative to the patient's venous system.
109. The method as recited in claim 108, wherein the method
includes the steps of inserting and securing the valve in one of
the inferior vena cava, superior vena cava, the hepatic vein, an
iliac vein, and pulmonary vein.
110. The method as recited in claim 108, wherein the method
includes a step of inserting and securing a tubular member with the
at least one valve adapted to be placed in the tubular member.
111. The method as claimed in claim 110, wherein the securing step
includes expanding the tubular member.
112. A device for treating heart failure in a patient, the device
comprising: a tube having first and second ends in fluid
communication with the left and right atriums of the heart
respectively; and a valve between the first and second ends and
adapted to selectively prevent or allow fluid flow through the
tube, wherein, the valve prevents fluid flow when the patient's
left atrial pressure is less than the patient's right atrial
pressure by a predetermined amount, and the valve opens when the
patient's left atrial pressure is greater than the right atrial
pressure to allow blood flow through the tube from the left atrium
to the right atrium to thereby reduce the left atrial pressure.
113. The device as recited in claim 112, wherein the valve is
closed when the pressure is less than the approximately 2 mm Hg and
opens when the predetermined amount of pressure differential is at
least approximately 2 mm Hg.
114. The device is claimed in claim 112, wherein the predetermined
pressure is between 5 to 25 mm Hg.
115. The device is claimed in claim 112, wherein the predetermined
pressure is approximately 5 to 15 mm Hg.
116. A medical device adapted to treat a medical condition
comprising: a tube having first and second ends in fluid
communication; and a one way valve disposed in the tube, the valve
prevents fluid flow when the patient's left atrial pressure is less
than the patient's right atrial pressure by approximately 2 mm Hg,
and the valve opens when the patient's left atrial pressure is
greater than the right atrial pressure by approximately 2 mm Hg to
allow blood flow through the tube from the left atrium to the right
atrium to thereby reduce the left atrial pressure.
117. A method for treating heart failure in a patient, the method
comprising the steps of: connecting a tube between the patient's
left and right atriums; and inserting a one way valve in the tube
that is oriented such that the one way valve allows blood flow
through the passage from the left atrium to the right atrium when
the patient's left atrial pressure exceeds the patient's right
atrial pressure, whereby, when the patient's left atrial pressure
exceeds the patient's right atrial pressure, by a predetermined
amount, the valve open to allow blood flow through the passage from
the left atrium to the right atrium to thereby reduce the patient's
left atrial pressure.
118. The method recited in claim 117, wherein the predetermined
amount of pressure differential is approximately 2 mm Hg.
119. The method recited in claim 118, wherein the predetermined
amount of pressure differential is approximately 5 to 25 mm Hg.
120. The device recited in claim 119, wherein the predetermined
amount of pressure differential is approximately 5 to 15 mm Hg.
121. A device for treating heart failure in a patient, the device
comprising: a body; a mounting surface on the body adapted to
secure the body in an opening provided in the patient's atrial
septum, an attachment system adapted for releasable engagement with
a cable in a delivery catheter and adapted to position the cable
substantially axially centrally relative to the body; and the body
defining at least one passage, and, at least one valve disposed in
the passage, the passage being otherwise substantially unobstructed
aside from the attachment system; wherein the at least one valve is
adapted to open and allow blood flow through the passage from the
left atrium to the right atrium to thereby reduce the left atrial
pressure when the patient's left atrial pressure exceeds the
patient's right atrial pressure by a predetermined amount and
prevent flow from the right atrium to the left atrium when the
right atrial pressure exceeds the left atrial pressure.
122. The device as recited in claim 121, wherein the attachment
system includes more than one point of contact on the body that are
symmetrically positioned on the body.
123. The device as recited in claim 122, wherein the attachment
system is disposed on the side of the body adjacent to a distal end
of the cable in the catheter.
124. The device as recited in claim 121, wherein the attachment
system includes one or more symmetrical struts connected to the
body.
125. The device as recited in claim 124, wherein the attachment
system is disposed on the side of the body remote a distal end of
the cable in the catheter, and the cable passes through the opening
and through the valve to engage the attachment system.
126. The device as recited in claim 121, wherein the attachment
system is adapted for threaded releasable engagement with the cable
in the catheter.
127. The device as recited in claim 121, wherein the valve is
selected from a group consisting of a duckbill valve, a leaflet
valve, a flap valve, a disc in cage type valve and ball in cage
type valve.
128. The device as claimed in claim 127, wherein the valve is
biased in a closed position.
129. The device as claimed in claim 128, wherein the valve is
constructed at least in part of resilient material and is biased to
the closed position by the inherent resilience of the valve
material.
130. A device for treating heart failure in a patient, the device
comprising: a body; a mounting surface on the body adapted to
secure the body in an opening provided in the patient's atrial
septum, an attachment system adapted for releasable engagement with
a cable in a delivery catheter and adapted to position the cable
substantially axially centrally relative to the body; and the body
defining at least one passage, and, at least one valve disposed in
the passage, the passage being otherwise substantially unobstructed
aside from the attachment system; wherein the at least one valve is
adapted to open and allow blood flow through the passage from the
left atrium to the right atrium to thereby reduce the left atrial
pressure when the patient's left atrial pressure exceeds the
patient's right atrial pressure by a predetermined amount of
pressure and prevent flow from the right atrium to the left atrium
when the right atrial pressure exceeds the left atrial pressure,
wherein the valve opens when the predetermined amount of pressure
differential is approximately 2 mm Hg.
131. The device as claimed in claim 121, wherein the at least one
valve opens when the predetermined amount of pressure differential
is approximately 5 to 25 mm Hg.
132. The device as claimed in claim 121, wherein the at least one
valve opens when the predetermined amount of pressure differential
is approximately 5 to 15 mm Hg.
133. The device as recited in claim 121 wherein the body defines a
single passage through the body into which a valve can be
located.
134. The device as claimed in claim 123, wherein the body includes
an axis and the single passage is centrally located along the axis
of the body.
135. The device as recited in claim 121, wherein the device is
constructed at least in part from a material which can be deformed
but later returned to its original shape.
136. The device as recited in claim 135, wherein the device is
formed from Nitinol.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to devices and
methods for the treatment of heart failure and, more particularly,
to devices and methods for the relief of high pressure in the
cardiovascular system to alleviate symptoms of cardiovascular
disease.
BACKGROUND OF THE INVENTION
[0002] Heart failure is a common and potentially lethal condition
affecting humans, with sub-optimal clinical outcomes often
resulting in symptoms, morbidity and/or mortality, despite maximal
medical treatment. In particular, "diastolic heart failure" refers
to the clinical syndrome of heart failure occurring in the context
of preserved left ventricular systolic function (ejection fraction)
and in the absence of major valvular disease. This condition is
characterised by a stiff left ventricle with decreased compliance
and impaired relaxation, which leads to increased end-diastolic
pressure. Approximately one third of patients with heart failure
have diastolic heart failure and there are very few, if any, proven
effective treatments.
[0003] Symptoms of diastolic heart failure are due, at least in a
large part, to an elevation in pressure in the left atrium. In
addition to diastolic heart failure, a number of other medical
conditions, including systolic dysfunction of the left ventricle
and valve disease, can lead to elevated pressures in the left
atrium. Increased left atrial pressure often causes acute or
chronic breathlessness amongst other problems. In addition, a
variety of heart conditions can lead to "right heart failure",
which can result in enlargement of the liver (hepatomegaly), fluid
accumulation in the abdomen (ascites) and/or swelling of the lower
limbs.
[0004] In the past, strategies have been described for the relief
of high pressure in the right atrium, such as the creation of
hole(s) in the native or surgically created septum between the left
and right atria. These have been designed for the rare conditions
of pulmonary hypertension or cavopulmonary connections for certain
complex congenital heart diseases. O'Loughlin et al recently
described a fenestrated atrial septal defect closure device for the
palliation of advanced pulmonary hypertension. However, this device
allows bidirectional flow, and the passage of thrombi, and was
shown to be closed over within 6 months of insertion. Thus a need
still exists for devices to relieve high pressure in the left
atrium and which will prevent or minimize the chance of the passage
of thrombi.
[0005] Accordingly, there exists a need for devices and methods to
treat heart failure particularly diastolic and/or systolic failure
of the left ventricle and its consequences.
SUMMARY OF THE INVENTION
[0006] According to a first aspect of the invention, there is
provided a device for treating heart failure in a patient, the
device comprising: [0007] a body; [0008] at least one passage
through the body; [0009] at least one one way valve in the passage;
and [0010] a mounting means adapted for mounting the body in an
opening provided in the patient's atrial septum, [0011] wherein, in
use, the device is oriented such that, when the patient's left
atrial pressure exceeds the patient's right atrial pressure by a
predetermined amount, the one way valve(s) opens to allow blood
flow through the passage(s) from the left atrium to the right
atrium to thereby reduce the left atrial pressure.
[0012] According to a second aspect of the invention, there is
provided a device for treating heart failure or pulmonary venous
hypertension in a patient, the device comprising: [0013] a body;
[0014] at least one passage through the body; [0015] at least one
one way valve in the passage; and [0016] a mounting means adapted
for mounting the body in the patient's venous system, [0017]
wherein, in use, the device is oriented such that the one way
valve(s) prevents blood flow through the passage(s) in a direction
opposite to that of the natural flow direction.
[0018] The device is preferably adapted to be fitted into a blood
vessel in the patient's venous system, such as the inferior vena
cava, superior vena cava, the hepatic vein, an iliac vein, or one
or more pulmonary veins.
[0019] According to a third aspect of the invention, there is
provided a device for treating lower limb venous hypertension in a
patient, the device comprising: [0020] a body; [0021] at least one
passage through the body; [0022] at least one one way valve in the
passage; and [0023] a mounting means adapted for mounting the body
in the patient's lower limb venous system, [0024] wherein, in use,
the device is oriented such that the one way valve(s) prevents
blood flow through the passage(s) in a direction opposite to that
of the natural flow direction.
[0025] The above device is also suitable for treating varicose
veins.
[0026] The body is preferably in the form of a stent, most
preferably an expandable stent.
[0027] The valve is preferably a duckbill valve, a leaflet valve, a
flap valve, a disc in cage type valve or a ball in cage type valve.
The valve is preferably biased to a closed position, most
preferably by the inherent resilience of the valve material. The
valve preferably opens when the predetermined amount of pressure
differential is at least approximately 2 mm Hg, preferably
approximately 5 to 25 mm Hg, even more preferably 5 to 15 mm
Hg.
[0028] In one form, the device has a single passage through the
body, most preferably centrally located in relation to the body. In
another form, the device has a single passage through the body,
most preferably eccentrically located in relation to the body. In
yet another form, the device has a plurality of passages through
the body, each with a one way valve therein, most preferably each
eccentrically located in relation to centre of the body.
[0029] According to a fourth aspect of the invention, there is
provided a device for treating heart failure in a patient, the
device comprising: [0030] a body; [0031] at least one passage
through the body; [0032] a mesh or grill arrangement within the
passage and having apertures therein of a size permitting flow of
blood, whilst substantially excluding thrombi, therethrough; [0033]
a mounting means adapted for mounting the body in an opening
provided in the patient's atrial septum, [0034] wherein, in use,
the device allows blood flow through the passage(s) from the left
atrium to the right atrium when the patient's left atrial pressure
exceeds the patient's right atrial pressure to thereby reduce the
patient's left atrial pressure.
[0035] The device preferably includes a mesh or grill arrangement
across one or both ends of the passage(s).
[0036] The apertures preferably have a maximum dimension of less
than 4 mm, most preferably less than 2 mm. The mesh or grill is
preferably coated or impregnated with one or more drugs, adapted
for preventing thrombosis or endothelialisation of the opening in
the patient's atrial septum, including an anticoagulant substance,
such as heparin, or an inhibitor of re-endothelialisation, such as
sirolimus or paclitaxel
[0037] In one form, the device has a single passage through the
body, most preferably centrally located in relation to the body. In
another form, the device has a plurality of passages through the
body, each with a mesh or grill arrangement therein, most
preferably each eccentrically located in relation to centre of the
body.
[0038] The device is preferably flexible, most preferably formed
from a material which can be deformed but later return to its
original shape. An example of such a material is Nitinol.
[0039] The device is preferably collapsible and adapted for
implanting via a catheter, although it could be inserted at
surgery.
[0040] The device is preferably collapsible to a size able to pass
through an opening made in the patient's atrial septum (or an
enlargement of a pre-existing communication, by standard methods)
and adapted to return to a shape where at least some of the device
would have been unable to pass through the opening in the patient's
atrial septum. The device is preferably formed from a Nitinol mesh,
or any other material which can be deformed but later return to its
original shape.
[0041] The mounting means preferably comprises at least one flange
having a dimension larger than the opening in the patient's septum.
More preferably, the mounting means preferably comprises a pair of
spaced apart flanges having a dimension larger than the opening in
the patient's septum.
[0042] The external dimension of the body, remote the flange(s), is
preferably substantially equal to the opening in the patient's
atrial septum.
[0043] In one embodiment, the flanges are adapted for gluing,
suturing, stapling or pinning to the patient's septum.
[0044] In another embodiment, the flanges are spaced apart by about
the thickness of the patient's atrial septum and are adapted to
locate, most preferably by gripping, the patient's atrial septum
therebetween.
[0045] According to a fifth aspect of the invention, there is
provided a method for treating heart failure in a patient, the
method comprising the steps of: [0046] forming an opening in the
patient's atrial septum; [0047] inserting at least one one way
valve in the opening that is oriented such that the one way
valve(s) allows blood flow through the passage from the left atrium
to the right atrium when the patient's left atrial pressure exceeds
the patient's right atrial pressure; and [0048] securing the one
way valve(s) relative to the patient's atrial septum, [0049]
whereby, when the patient's left atrial pressure exceeds the
patient's right atrial pressure by a predetermined amount, the
valve opens to allow blood flow through the passage(s) from the
left atrium to the right atrium to thereby reduce the patient's
left atrial pressure.
[0050] The above method is particularly suited for treating
cardiovascular disease manifest by left atrial hypertension, such
as that due to left ventricular systolic or diastolic
dysfunction.
[0051] The predetermined amount of pressure differential is at
preferably least approximately 3 mm Hg, preferably approximately 5
to 25 mm Hg, even more preferably 5 to 15 mm Hg.
[0052] According to a sixth aspect of the invention, there is
provided a method for treating heart failure in a patient, the
method comprising the steps of: [0053] forming an opening in the
patient's atrial septum; [0054] inserting a mesh or grill
arrangement within the opening having apertures therein of a size
permitting passage of blood, whilst substantially excluding passage
of thrombi, therethrough; and [0055] securing the mesh or grill
arrangement relative to the patient's atrial septum.
[0056] The mesh or grill arrangement is preferably provided within
a passage in a body, and the method preferably includes the step of
securing the body relative to the patient's atrial septum.
[0057] The above method is particularly suited for treating
cardiovascular disease manifest by left atrial hypertension, such
as that due to left ventricular systolic or diastolic
dysfunction.
[0058] According to a seventh aspect of the invention, there is
provided a method for treating heart failure in a patient, the
method comprising the steps of: [0059] inserting at least one one
way valve in the patient's venous system that is oriented such that
the one way valve(s) prevents blood flow through the said venous
system in a direction opposite to that of the natural flow
direction; and [0060] securing the one way valve(s) relative to the
patient's venous system.
[0061] The method preferably includes the steps of inserting and
securing the one way valve in the patient's blood vessel, such as
the inferior vena cava, superior vena cava, the hepatic vein, an
iliac vein, or one or more pulmonary veins.
[0062] The method preferably includes a step of inserting and
securing, most preferably by expanding, a stent with the one way
valve(s) therein.
[0063] According to an eighth aspect of the invention, there is
provided a device for treating heart failure in a patient, the
device comprising: [0064] a tube having first and second ends in
fluid communication with the left and right atriums of the heart
respectively; and [0065] a valve between the first and second ends
and adapted to selectively prevent or allow fluid flow through the
tube, [0066] wherein, in use, when the patient's left atrial
pressure exceeds the patient's right atrial pressure by a
predetermined amount, the valve opens to allow blood flow through
the tube from the left atrium to the right atrium to thereby reduce
the left atrial pressure.
[0067] The valve opens when the predetermined amount of pressure
differential is at preferably least approximately 2 mm Hg,
preferably approximately 5 to 25 mm Hg, even more preferably
approximately 5 to 15 mm Hg.
[0068] According to an ninth aspect of the invention, there is
provided a device for treating heart failure or pulmonary venous
hypertension in a patient, the device comprising: [0069] a tube
having first and second ends in fluid communication with the left
and right atriums of the heart respectively; and [0070] a one way
valve in the tube, [0071] wherein, in use, the one way valve
prevents blood flow through the tube from the right atrium to the
left atrium
[0072] According to a tenth aspect of the invention, there is
provided a method for treating heart failure in a patient, the
method comprising the steps of: [0073] connecting a tube externally
between the patient's left and right atriums; and [0074] inserting
a one way valve in the tube that is oriented such that the one way
valve allows blood flow through the passage from the left atrium to
the right atrium when the patient's left atrial pressure exceeds
the patient's right atrial pressure, [0075] whereby, when the
patient's left atrial pressure exceeds the patient's right atrial
pressure, by a predetermined amount, the valve open to allow blood
flow through the passage(s) from the left atrium to the right
atrium to thereby reduce the patient's left atrial pressure.
[0076] The predetermined amount of pressure differential is at
preferably least approximately 2 mm Hg, preferably approximately 5
to 25 mm Hg, even more preferably approximately 5 to 15 mm Hg.
BRIEF DESCRIPTION OF THE DRAWINGS
[0077] Preferred embodiments of the invention will now be
described, by way of examples only, with reference to the
accompanying drawings in which:
[0078] FIG. 1 is a front view of a first embodiment of a device for
treating heart failure;
[0079] FIG. 2 is a cross sectional side view of the device shown in
FIG. 1;
[0080] FIG. 3 is a cross sectional side view of the device shown in
FIGS. 1 and 2 implanted in a human heart;
[0081] FIG. 4 is a rear view of the device shown in FIG. 1;
[0082] FIG. 5 is a front view of a second embodiment of a device
for treating heart failure;
[0083] FIG. 6 is a front view of a third embodiment of a device to
treat heart failure;
[0084] FIG. 7 is a cross sectional side view of the device shown in
FIG. 6;
[0085] FIG. 8 is a front view of a fourth embodiment of a device to
treat heart failure;
[0086] FIG. 9 is a cross sectional side view of the device shown in
FIG. 8;
[0087] FIG. 10 is a cross sectional side view of a fifth embodiment
of a device for treating heart failure;
[0088] FIG. 11 is a cross sectional side view of the device shown
in FIG. 10 implanted in a patient's inferior vena cava;
[0089] FIG. 12 is a cross sectional side view of a first embodiment
of a delivery mechanism for the device shown in FIG. 10;
[0090] FIG. 13 is a cross sectional side view of a second
embodiment of a delivery mechanism for the device shown in FIG.
10;
[0091] FIG. 14 is a cross sectional side view of a sixth embodiment
of a device for treating heart failure implanted in a patient's
hepatic vein;
[0092] FIG. 15 is a cross sectional side view of a pair of the
devices shown in FIG. 14 implanted in a patient's iliac veins;
[0093] FIG. 16 is a front view of a seventh embodiment of a device
for treating heart failure;
[0094] FIG. 17 is a front view of an eighth embodiment of a device
for treating heart failure;
[0095] FIG. 18 is a cross sectional side view of the device shown
in FIG. 17;
[0096] FIG. 19a is a front view of a ninth embodiment of a device
for treating heart failure;
[0097] FIG. 19b is a cross sectional side view the device shown in
FIG. 19a;
[0098] FIG. 20 is a front view of a tenth embodiment of a device
for treating heart failure,
[0099] FIG. 21a is a cross sectional side view of an eleventh
embodiment of a device for treating heart failure, collapsed within
a catheter;
[0100] FIG. 21b is a cross sectional perspective view of the device
shown in FIG. 21a, collapsed within a catheter;
[0101] FIG. 22a is a cross sectional side view of the device shown
in FIG. 21a, partially deployed from the catheter;
[0102] FIG. 22b is a cross sectional perspective view of the device
shown in FIG. 21a, partially deployed from the catheter;
[0103] FIG. 22c is an enlarged, partial cross sectional side view
of the device shown in FIG. 21a, partially deployed from the
catheter;
[0104] FIG. 23a is a side view of the device shown in FIG. 21a,
deployed from the catheter;
[0105] FIG. 23b is a cross sectional side view of the device shown
in FIG. 21a, deployed from the catheter; and
[0106] FIG. 24 is a cross sectional side view of a twelfth
embodiment of a device for treating heart failure.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0107] FIGS. 1 to 4 show a first embodiment of a device 10 for
treating heart failure. The device 10 includes a generally
cylindrical body 12 with a mounting means, in the form of a pair of
annular flanges 14 at either end with an annular gap 16
therebetween. The body 12 has a centrally located passage or duct
18 within which is provided a one way valve 20, in the form of
three flexible valve leaflets 20a to 20c.
[0108] The external diameters of the body 12, the flanges 14 and
internal diameter of the passage 18 are approximately 18, 38 and 12
mm respectively. In other embodiments (not shown), the diameter of
the body 12 ranges from 8 to 25 mm, the diameter of the flanges 14
ranges from 20 to 50 mm, and the diameter of the passage 18 ranges
from 4 to 15 mm,
[0109] FIG. 3 shows a patient's heart 22 with a left atrium 24 and
a right atrium 26 separated by an atrial septum 28. The device 10
is mounted within a generally circular opening 30 made in the
septum 28 and with the edges of the septum 28 adjacent the opening
30 positioned in the gap 16 between the flanges 14. The opening 30
has an internal diameter approximately equal to the external
diameter of the body 12. The device 10 is retained adjacent the
opening 30 in the septum 28 as the flanges 14 are larger, and thus
cannot pass through, the opening 30. Alternatively, or in addition,
one or both of the flanges 14 can be glued, sutured, stapled or
pinned to the patient's septum 28 to secure the device 10
thereto.
[0110] The device 10 can be implanted during open heart surgery or
percutaneously using a catheter. In either case, the opening 30 is
firstly fashioned in the patient's atrial septum 28. Some or all of
the device 10 is then collapsed to a size able to pass through the
opening 30 and subsequently expanded to the configuration shown in
FIG. 3. Forming the s body 12 and the flanges 14 of the device 10
from a Nitinol wire mesh result in it being suitable for implanting
in a manner similar to the implanting of the AMPLATZER (Trade Mark)
septal occluder produced by AGA Medical Corp. More particularly,
the exterior faces of the flanges 14 are pulled away from one
another which causes the device 10 to lengthen and simultaneously
reduce in diameter for fitting within a catheter able to pass
through the opening 30. When the separating force is then removed
the flanges 14 return to the (expanded) configuration in FIGS. 1 to
4.
[0111] The device 10 is orientated during implanting with the one
way valve 20 only allowing blood flow through the passage 18 from
the left atrium 24 to the right atrium 26, as indicated by arrows
32. More particularly, when the left atrial pressure exceeds the
right atrial pressure by about 5-15 mm Hg, the valve leaflets 20a
to c separate and thus open the passage 18 to blood flow from the
left atrium 24 to the right atrium 26.
[0112] The leaflets 20a to 20c are formed from biological,
mechanical or engineered tissue and are inherently biased towards a
closed position. Further, the patient's right atrial pressure
exceeding the left atrial pressure also assists in the closing, and
the maintaining closed, of the valve 20.
[0113] The relief and/or avoidance of the left atrial pressure
significantly exceeding the right atrial pressure is beneficial in
alleviating the adverse consequences of left atrial hypertension
complicating cardiovascular diseases, including left ventricular
systolic and/or diastolic dysfunction and/or valvular diseases.
[0114] As best seen in FIG. 4, the device 10 includes four thin
collapsible struts 34 connected to a central fixture or boss 36
having an internally threaded opening. A cable (not shown) is
threadedly attachable to the fixture 36. The fixture 36 is
accessible from the left atrium.
[0115] To implant the device 10, it is firstly collapsed inside a
catheter. When the catheter is correctly positioned adjacent the
opening 30, the cable is used to push the device 10 out of the
catheter, whereafter it expands to the shape shown in FIG. 3. The
cable is then unscrewed from the fixture 36 and removed from the
patient with the catheter.
[0116] The device 10 can also be adapted to allow later removal by
a percutaneous route, for example by the placement of small hooks
(not shown) on a surface of the device 10 that is closest to a
nearby venous access site.
[0117] FIGS. 5 shows a second embodiment of a device 40 for
treating heart failure. The construction, function and implanting
of the device 40 is similar to that of the device 10 and like
reference numerals are used to indicate like features between the
two embodiments. However, the device 40 has four eccentrically
located passages 18 through the body 12 and blood flow therethrough
is controlled by four corresponding sets of valve leaflets 20.
[0118] FIGS. 6 and 7 show a third embodiment of a device 50 for
treating heart failure. The construction, operation and
implantation of the device 50 is similar to that of the device 10
and like reference numerals are used to indicate like features
between the two embodiments. However, the device 50 has only one
collapsible strut 34 connected to a central fixture 36, to which a
cable 52 can be attached. The fixture 36 is also accessible from
the left atrium. In a variation of this embodiment, the fixture is
accessible from the right atrium.
[0119] FIGS. 8 and 9 show a fourth embodiment of a device 60 for
treating heart failure. The construction, function and implanting
of the device 60 is similar to that of the device 10 and like
reference numerals are used to indicate like features between the
two embodiments. However, the device 60 has three fixtures 36
attached to the body 12, adjacent the passage 18, to which three
respective cables 62 (see FIG. 9) can be attached. The fixtures 36
are accessible from the right atrium.
[0120] FIGS. 10 and 11 show a fifth embodiment of a device 70 for
treating heart failure, in a manner similar to that of the device
10. However, unlike the earlier embodiments, the device 70 only has
a single mounting flange 14 which, as shown in FIG. 11, makes it
suitable for implanting in the inferior vena cava 72 at or near the
junction with the right atrium 74. The device 70 is preferably
produced from a deformable material that can resume its preformed
shape (such as Nitinol) and may be implanted by a percutaneous
approach.
[0121] More particularly, the device 70 is collapsed and introduced
in the venous system within a sheath, and removed from the sheath
to expand when correctly positioned.
[0122] FIGS. 12 and 13 show two mechanisms suitable for delivering
the device 70 to the inferior vena cava. The mechanism shown in
FIG. 12 is similar to that shown in FIGS. 6 and 7 and the mechanism
shown in FIG. 13 is similar to that shown in FIGS. 8 and 9.
[0123] FIG. 14 is a cross sectional side view of a sixth embodiment
of a device 80 for treating heart failure, implanted in a patient's
hepatic vein 82. The device 80 does not include any mounting
flanges and it's body is instead an expandable stent 84 with a one
way valve 20 therein.
[0124] FIG. 15 shows an alternative implanting of the device 80 in
a patient's iliac veins 84 and 86.
[0125] The device 80 is also suitable for placement in the venous
system of the lower limb or iliac system to relieve the signs or
symptoms of lower limb hypertension (e.g. peripheral oedema and/or
varicose veins).
[0126] FIG. 16 shows a seventh embodiment of a device 90 for
treating heart failure. The construction, function and implanting
of the device 90 is similar to that of the device 40 and like
reference numerals are used to indicate like features between the
two embodiments. However, the device 90 has only two eccentrically
located passages 18 through the body 12 and blood flow therethrough
is controlled by two corresponding sets of valve leaflets 20.
[0127] FIG. 17 shows an eighth embodiment of a device 100 for
treating heart failure. This embodiment is constructed and
implanted in a similar manner to that previously described.
However, the device 100 has a passage 18 therethrough with a mesh
or grill arrangement 102 across each end of the passage 18. The
mesh 102 has apertures 104 therein of a maximum dimension of less
than 4 mm which permit the flow of blood from the left to the right
atrium through the passage 18, whilst substantially excluding
thrombi. The mesh 102 is coated or impregnated with one or more
drugs, adapted for preventing thrombosis or endothelialisation of
the opening in the patient's atrial septum, including an
anticoagulant substance, such as heparin, or an inhibitor of
re-endthelialisation, such as sirolimus or paclitaxel
[0128] FIGS. 19a and 19b show a ninth embodiment of a device 110
for treating heart failure. The construction, operation and
implantation of the device 110 is similar to that of the device 10
and like reference numerals are used to indicate like features
between the two embodiments. The device 110 utilizes a
strut/fixture arrangement similar to that shown in FIGS. 6 and
7.
[0129] FIG. 20 shows a tenth embodiment of a device 130 for
treating heart failure. The construction, operation and
implantation of the device 130 is similar to that of the device 10
and like reference numerals are used to indicate like features
between the two embodiments. The device 130 has a helical groove
132 for releasably engaging a corresponding fitting on the end of a
catheter cable during implantation.
[0130] FIGS. 21a to 23b show an eleventh embodiment of a device 140
for treating heart failure. The construction, operation and
implantation of the device 100 is similar to that of the device 10
and like reference numerals are used to indicate like features
between the two embodiments. The body 12 and the flanges 14 of the
device 140 are formed from a Nitinol wire mesh which result in it
being suitable for implanting in a manner similar to the implanting
of the AMPLATZER (Trade Mark) septal occluder produced by AGA
Medical Corp. The device 140 is collapsed by pulling the exterior
faces of the flanges 14 away from one another which causes the
device 140 to lengthen and simultaneously reduce in diameter. When
the separating force is removed the flanges 14 return to the
(expanded) configuration.
[0131] More particularly, as shown in FIGS. 21a and 21b, the device
140 is initially collapsed within a catheter 142 of about 5 mm in
diameter, which is able to pass through an opening in the septum.
As shown in FIGS. 22a to 22c, the device 140 is then partially
deployed from the catheter 142 by movement of wire 144, and thus
head 146, relative to the catheter 142. This results in part of the
device 140 expanding to form the first flange 14.
[0132] As shown in FIGS. 23a and 23b, fall deployment of the device
140 by further relative movement of the wire 144 and the head 146,
relative to the catheter 142, results in the remainder of the
device 140 expanding to form the second flange 14. The device 140
is initially attached to the head 146 by three pins 148, which are
remotely released after the device has been deployed from the
catheter 142.
[0133] In other similar embodiments (not shown) the catheter 142
has a diameter of 4-6 mm and the device 140 is initially attached
to the head 146 by one or two releasable pins 148.
[0134] FIG. 20 shows a twelfth embodiment of a device 150 for
treating heart failure. In this embodiment, a tube 152 of about 8
mm internal diameter provides an external fluid communication path
between the heart's left and right atriums 154 and 156
respectively. A valve 158 is adapted to selectively occlude the
tube 152. As with earlier embodiments, when the left atrial
pressure exceeds the right atrial pressure by about 5-15 mm Hg, the
valve 158 is released to open the interior of the tube 152 and
allow blood flow from the left atrium 24 to the right atrium 26. In
a variation of this embodiment, the valve 158 is a one way valve
that prevents blood flow from the right atrium 156 to the left
atrium 154.
[0135] Although the invention has been described with reference to
the specific examples it will be appreciated by those skilled in
the art that the invention may be embodied in many other forms.
* * * * *